UltraGene Combo2Screen SARS-CoV-2 Assay

Description

The UltraGene Combo2Screen SARS-CoV-2 Assay is a real-time RT-PCR test (nucleic acid technique (NAT)) intended to be used for the qualitative detection of nucleic acids from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) and directed against the E and N genes of SARS-CoV-2 virus.

Methodology

Application - For Research Use Only (RUO)

Except for certain territories – For Research Use Only (RUO). Not for use in diagnostic procedures. No claim or representation is intended to provide information for the diagnosis, prevention, or treatment of disease.
The ABL’s UltraGene Combo2Screen SARS-Cov-2 Assay is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test for the qualitative detection of RNA from SARS-CoV-2. The test is targeting E (Envelop) and N (Nucleocapsid) regions of the viral genome.
The product is intended for use by professional users in laboratories able to work with biohazardous material like hospital laboratories, reference laboratories, private laboratories or government laboratories.

The current laboratory biosafety guidance for the 2019 novel coronavirus (SARS-CoV-2) shall be followed (https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html).
Results are for the identification of SARS-CoV-2 from extracted RNA samples. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal and oropharyngeal swabs during the acute phase of infection.

INTENDED USE - FDA-EMERGENCY USE ONLY

The UltraGene Combo2Screen SARS-CoV-2 Assay is a real-time RT-PCR test (nucleic acid technique (NAT)) intended to be used for the qualitative detection of nucleic acids from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen to aid the diagnosis of coronavirus disease (Covid-19) infection.

The UltraGene Combo2Screen SARS-CoV-2 Assay is for use only under Emergency Use Authorization (EUA) in U.S. laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate complexity tests, and in U.S. laboratories certified under CLIA to perform high complexity tests.

The UltraGene Combo2Screen SARS-CoV-2 Assay is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

When allowing for 1 mismatch, we aligned all primers and probes of the UltraGene Combo2Screen SARS-CoV-2 Assay to 100% of the inclusivity study sequences (n=413)

Cross-reactivity (in-silico)

For the N gene primers and probe, we identified no potentially unintended targets. Even though the forward and reverse primers may amplify a target region in SARS coronavirus, the probe would not bind to the amplicon.
The primers and probe of the E gene may amplify and detect the SARS and Bat coronaviruses and were not specific with an 80% identity threshold. Few other nonspecific bindings were found but would not result in either an amplification or detection
The primers and probe for the N gene were specific to SARS-CoV-2.

For each target, E and N genes of the SARS-CoV-2, sixty samples (n=60) were randomly and blindly distributed over 3 instrument-runs by a person, different from the technician who handled the specimens and processed them.
All negative samples (n=30) yielded negative results (100%)
All samples at 1,5*LoD (n=20) and 4*LoD (n=10) were positive (100%)